LBEClass I
Stroller, Adaptive
Physical Medicine · 21 CFR 890.3850
MDR events8All time
Recalls0All time
Registered firms9Currently listed
510(k) clearances8All time
Recent MDR events
8 adverse event reports on file
- LITTLE WAVEJan 16, 2025MalfunctionKi Mobility3005905321-2025-00001
- LITTLE WAVE FLIPMay 15, 2024InjuryKi Mobility3005905321-2024-00006
- LITTLE WAVE FLIPDec 22, 2022MalfunctionKi Mobility, Llc3005905321-2022-00006
- ZIPPIE VOYAGEOct 19, 2017MalfunctionSunrise Medical Privada Misiones9616084-2017-00011
- ZIPPIE VOYAGEOct 5, 2017MalfunctionSunrise Medical Privada Misiones9616084-2017-00009
- ZIPPIE VOYAGEAug 15, 2017MalfunctionSunrise Medical Privada Misiones9616084-2017-00004
- SUSPEND SEAT STROLLERFeb 18, 1997Care Products68723
- SUSPENDED SEAT STROLLERJan 23, 1997InjuryCare Products1417592-1997-00004
Event type breakdown
Malfunction5
Injury2
Unspecified1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
9 firms currently registered for this product code
510(k) clearances
8 clearances for this product code
- Ki Mobility, LLCAug 31, 2023
K223533 · Little Wave Arc; Little Wave Flip
- Columbia Medical Mfg, LLCOct 16, 2013
K130644 · PEDIATRIC FOLDING WHEELCHAIR
- Asc Corp.Oct 23, 1986
K863450 · SULKY SPECIAL
- Mednet, Inc.Aug 13, 1986
K862888 · PERAMBULATOR (STROLLER)
- Convaid Products, Inc.Feb 9, 1984
K840250 · CARRIER
- Kaye Products, Inc.Mar 15, 1982
K820591 · MECHANICAL CHAIR
- Convaid Products, Inc.Mar 26, 1981
K810676 · CONVAID CRUISER CP4M
- Convaid Products, Inc.Dec 4, 1978
K781947 · STROLLER, THERAPY